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SHR Neuro Cancer Cardio Lipid Metab Microb

Tepe, G; Brodmann, M; Werner, M; Bachinsky, W; Holden, A; Zeller, T; Mangalmurti, S; Nolte-Ernsting, C; Bertolet, B; Scheinert, D; Gray, WA, , Disrupt, PAD, III, Investigators.
Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial.
JACC Cardiovasc Interv. 2021; 14(12): 1352-1361. Doi: 10.1016/j.jcin.2021.04.010
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Brodmann Marianne

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Abstract:

OBJECTIVES: The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease. BACKGROUND: Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification. METHODS: The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab-adjudicated procedural success (residual stenosis ≤30% without flow-limiting dissection) prior to DCB or stenting. RESULTS: In patients receiving IVL (n = 153) or PTA (n = 153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p = 0.01) and the percentage of lesions with residual stenosis ≤30% (66.4% vs. 51.9%; p = 0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p = 0.03). Post-dilatation (5.2% vs. 17.0%; p = 0.001) and stent placement (4.6% vs. 18.3%; p < 0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p = 0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p = 1.0) at 30 days were comparable between groups. CONCLUSIONS: IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193).

Find related publications in this database (using NLM MeSH Indexing)

Angioplasty, Balloon - adverse effects

Coated Materials, Biocompatible - administration & dosage

Femoral Artery - diagnostic imaging

Humans - administration & dosage

Lithotripsy - adverse effects

Peripheral Arterial Disease - diagnostic imaging, therapy

Popliteal Artery - diagnostic imaging

Prospective Studies - administration & dosage

Treatment Outcome - administration & dosage

Vascular Calcification - diagnostic imaging, therapy

Vascular Patency - administration & dosage

Find related publications in this database (Keywords)

drug-coated balloon

femoropopliteal artery

intravascular lithotripsy

peripheral artery disease

calcification

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